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Disposable Electrosurgical Knife
EUDAMEDClass IIb (EU MDR)
Ref EK18-O24/1800, EK18-O24/2300, EK18-L24/1800, EK18-L24/2300
Identity
- Trade Name
- Disposable Electrosurgical Knife EUDAMED
- Device Name
- Disposable Electrosurgical Knife EUDAMED
- Model / Reference
- EK18-O24/1800, EK18-O24/2300, EK18-L24/1800, EK18-L24/2300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EK18HY EUDAMED
- Basic UDI-DI
- B-EK18HY EUDAMED
- EMDN Code
- K0299 ELECTROSURGERY DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Percutaneous radio-frequency ablation system generator
Disposable Electrosurgical Knife by Beijing ZKSK Technology Co., Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Percutaneous radio-frequency ablation system generator.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-EK18HY | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED bf9f8e81-6f19-41d0-a8dc-350979ddfb13 61 fields · synced Jul 12, 2026
- EUDAMED bf9f8e81-6f19-41d0-a8dc-350979ddfb13-1 61 fields · synced Jun 10, 2026